K862184 is an FDA 510(k) clearance for the DAKO ITA, IMMUNOGLOBULIN M (IGM). This device is classified as a Gamma Globulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DAH).
Submitted by Dako Corp. (Santa Barbara, US). The FDA issued a Cleared decision on August 19, 1986, 71 days after receiving the submission on June 9, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K862184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1986 |
| Decision Date | August 19, 1986 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAH — Gamma Globulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |